(69 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and bioabsorbability of a physical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an interference screw used for surgical fixation of tissue, not a therapeutic device that delivers therapy.
No
Explanation: The device is an interference screw intended for fixation of tissue to bone during surgical repairs, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, bioabsorbable interference screw made from specific materials and with defined dimensions. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Arthrex FastThread™ Interference Screws are for the fixation of tissue (ligament, tendon, bone) during surgical procedures. This is a direct therapeutic intervention within the body.
- Device Description: The device is a physical implantable screw made of bioabsorbable materials.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used outside the body to analyze samples (like blood, urine, tissue) to diagnose or monitor a medical condition. This device is used inside the body for surgical repair.
N/A
Intended Use / Indications for Use
The Arthrex FastThread™ Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tenair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The Arthrex FastThread™ Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, elbow, ankle, foot, and hand/wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pullout testing at time zero and after 16 weeks degradation and insertion testing was conducted to demonstrate that the proposed Arthrex FastThread™ Interference Screw performs statistically equivalent to the predicate. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
May 22, 2018
Arthrex Inc. Jessica L. Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K180662
Trade/Device Name: Arthrex FastThread™ Interference Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: April 19, 2018 Received: April 23, 2018
Dear Ms. Singelais:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180662
Device Name Arthrex FastThread™ Interference Screw
Indications for Use (Describe)
The Arthrex FastThread™ Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tenair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | May 17, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica L. Singelais |
| Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.singelais@arthrex.com | |
| Name of Device | Arthrex FastThread™ Interference Screw |
| Common Name | Screw, fixation, bone |
| Product Code | MAI, HWC |
| Classification Name | 888.3030 Single/multiple component metallic bone fixation appliances and |
| accessories | |
| 888.3040 Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K071176: Arthrex Interference Screw |
| Purpose of | This Special 510(k) premarket notification is submitted to obtain clearance for a |
| Submission | line extension to the Arthrex BioComposite Interference Screw family cleared |
| under K071176. | |
| Device Description | The Arthrex FastThread™ Interference Screw is a cannulated, fully threaded, |
| bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium | |
| Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter | |
| and 20-30 mm in length. | |
| Indications for Use | The Arthrex FastThread Interference Screws are intended to be used for fixation |
| of tissue, including ligament or tendon to bone, or a bone/tendon to bone. | |
| Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, | |
| ankle, foot, and hand/wrist where the sizes offered are patient appropriate; | |
| specifically, | |
| Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps | |
| Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or | |
| Capsulolabral Reconstruction | |
| Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, | |
| Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament | |
| Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon | |
| transfers in the foot and ankle | |
| Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, | |
| Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique | |
| Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair | |
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament | |
| Reconstruction | |
| Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament | |
| Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint | |
| arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions | |
| and repairs, tendon transfer in the hand/wrist |
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| Comparison
Summary of
Technological
Characteristics and
Modifications
Proposed | The proposed and predicate devices have the same technological characteristics.
The proposed devices consist of a line extension to the predicate, which include
minor dimensional modifications, added fenestrations and a change in head
profile with no change in intended use or function.
The Arthrex FastThread™ Interference Screw is substantially equivalent to the
predicate device in which the basic design features and intended uses are the
same. Any differences between the proposed device and the predicate device are
considered minor and do not raise questions concerning safety or effectiveness. |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | Pullout testing at time zero and after 16 weeks degradation and insertion testing
was conducted to demonstrate that the proposed Arthrex FastThread™
Interference Screw performs statistically equivalent to the predicate.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that
the device meets pyrogen limit specifications. |
| Conclusion | Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. |